International Regulatory Strategy Director

Role Purpose & Context

Role Summary

As an International Regulatory Strategy Director, you'll be leading the charge on getting our products approved and keeping them compliant across multiple countries. This means you'll be looking after all the regulatory bits for a whole product family or a specific, big region. You're the one who develops the game plan, making sure we can actually sell our stuff where we want to. When you do this well, our new products hit the market faster, and we avoid those nightmare recalls or hefty fines. If you get it wrong, well, we're talking about market delays, lost revenue, and a serious hit to our reputation. The tricky part is that regulations are always changing, and what works in one country definitely won't work in another. But the reward? You get to see our innovations reach patients and customers worldwide, knowing you made it happen safely and legally.

Reporting Structure

• Reports to: Senior Manager, International Regulatory Strategy
• Direct reports: Typically 3-8 direct reports, often a mix of Regulatory Affairs Specialists and Senior Specialists.
• Matrix relationships: Regulatory Affairs Manager, Principal Regulatory Strategist, Lead Regulatory Specialist (International), Head of Regional Regulatory Affairs,

Key Stakeholders

Internal:

• Product Development Leads
• R&D Directors
• Quality Assurance Managers
• Commercial and Sales Leadership (Regional)
• Legal Counsel
• Executive Leadership (SVP/VP level)

External:

• Health Authorities (e.g., FDA, EMA, MHRA, TGA, Health Canada)
• Notified Bodies (for EU market)
• External Legal Advisors
• Industry Associations
• Contract Research Organisations (CROs)

Organisational Impact

Scope: Your work directly impacts our ability to launch and maintain products in key international markets. Get it right, and we're first to market, making money and helping people. Get it wrong, and we're looking at significant financial penalties, product withdrawals, and a damaged brand. Honestly, you're a gatekeeper for market access and a guardian of our reputation.

Performance Metrics

Quantitative Metrics

1. Metric: First-Pass Approval Rate for Submissions
2. Desc: This is about how often our regulatory submissions get approved without needing significant additional information or changes on the first go.
3. Target: Achieve >85% first-pass approval rate on all major submissions.
4. Freq: Quarterly, reviewed per submission type and region.
5. Example: If your team submits 10 major applications this quarter and 9 are approved without major queries, that's a 90% first-pass rate. We're looking for consistent quality here.
6. Metric: Average Agency Response Time Reduction
7. Desc: How quickly we get our products approved often depends on the quality of our initial submission. This measures if we're making it easier for agencies to say 'yes' faster.
8. Target: Reduce average agency response time by 10% for your product portfolio compared to the previous year.
9. Freq: Annually, tracked against historical data.
10. Example: If last year's average approval time was 120 days, we'd want to see that drop to around 108 days this year for your managed portfolio. It means less waiting, more selling.
11. Metric: Regulatory Project Deadline Adherence
12. Desc: This metric tracks how well your team sticks to the planned timelines for regulatory submissions and other key project milestones.
13. Target: Ensure 95% of regulatory projects and submissions meet their internal deadlines.
14. Freq: Monthly, reviewed against project plans.
15. Example: If a submission was planned for 15 May, but it went out on 17 May, that's a miss. We need you to keep things on track, especially when other teams are relying on your dates.
16. Metric: Team Productivity & Throughput
17. Desc: This looks at how many submissions or regulatory projects your team successfully completes within a given period, balanced with quality.
18. Target: Increase the number of successful submissions/approvals for your product portfolio by 10-15% year-on-year, without compromising quality.
19. Freq: Annually, reviewed against business growth and new market entries.
20. Example: If your team managed 20 new market entries last year, we'd expect to see around 22-23 this year, assuming similar complexity. It's about scaling our efforts.

Qualitative Metrics

1. Metric: Strategic Regulatory Counsel
2. Desc: You're not just a rule-book reader; you're a strategic advisor. This measures how often other teams come to you for proactive, strategic advice on product development or market entry.
3. Evidence: You're regularly invited to early-stage product planning meetings. Product and R&D teams actively seek your input before making major design decisions. Your advice shapes significant business decisions, like market entry priorities or product feature sets. People say things like, 'We need to run this by [Your Name] first.'
4. Metric: Team Development & Mentorship
5. Desc: As a Director, you're responsible for growing your team. This looks at how well you're coaching and developing your direct reports.
6. Evidence: Your direct reports show clear professional growth and take on more complex tasks. They feel supported and regularly ask for your guidance. Retention rates for your team are high, and you've successfully promoted at least one team member to a more senior role. You're seen as a fair and effective manager.
7. Metric: Proactive Risk Mitigation
8. Desc: This is about spotting potential regulatory issues before they become actual problems, and then putting a plan in place to deal with them.
9. Evidence: You present regular updates on emerging regulatory trends and their potential impact to senior leadership. You've identified and successfully mitigated at least one significant regulatory risk that could have led to a product delay or recall. Internal audit findings related to your areas are minimal or non-existent, and any issues are addressed swiftly and thoroughly.
10. Metric: Cross-Functional Influence & Collaboration
11. Desc: Your role requires you to get different departments on board with regulatory requirements, even when it's inconvenient for them. This measures your ability to do that smoothly.
12. Evidence: You're able to get Product, R&D, and Sales teams to adopt regulatory recommendations without major friction. You're seen as a partner, not a blocker. Other department leads actively seek your input and value your perspective in joint projects. You can get people to agree on a path forward even when initial opinions differ significantly.

Primary Traits

• Trait: Influential (Not just a rule-follower)
• Manifestation: You're the person who can get an engineering team to use a slightly more expensive material because it's more compliant, without them digging their heels in. You'll convince the marketing department to tweak product claims to reduce regulatory risk, and they'll actually listen. When you need a bigger budget for a critical compliance project, you'll successfully argue for it by linking it directly to avoiding a massive fine or market access. It's about getting people to *want* to do the right thing, not just telling them they have to.
• Benefit: Honestly, this job isn't just about knowing the rules inside out; it's about getting everyone else in the organisation—from engineers to marketers to sales—to actually follow them. Often, doing the right regulatory thing is inconvenient or costs money in the short term. If you can't influence, you'll end up being seen as just a 'department of no,' and your critical advice will get ignored. That's a recipe for disaster, frankly.
• Trait: Decisive (Under ambiguity)
• Manifestation: You're comfortable making a 'go/no-go' call on a major product submission even when the agency guidance is a bit vague or contradictory. You can interpret a brand-new regulation with no clear precedent and then confidently create a company-wide policy based on your best judgment. You might even advise the CEO to pull a product from a market because of an evolving political risk that could impact regulatory standing. It's about taking calculated risks, not waiting for perfect clarity.
• Benefit: The reality is, regulatory affairs rarely gives you perfect, black-and-white answers. You'll often be working with incomplete information, especially in new or evolving international markets. You simply have to be comfortable making high-stakes decisions based on your risk assessment and strategic judgment. And yes, you'll be held accountable for those outcomes, so you need to back your calls with solid reasoning and conviction.
• Trait: Meticulously Precise (Verging on pedantic)
• Manifestation: You're the one who'll spot that a date format is DD-MM-YYYY in one part of a 2,000-page submission and MM-DD-YYYY in another section, knowing that inconsistency could cause a delay. You'll catch a subtle but critical difference between the EU and UK versions of what looks like the same regulation. You'll insist on exact, consistent terminology across all technical documentation, because you know a slight variation can change the meaning entirely. You're basically a human spell-checker and fact-checker on steroids.
• Benefit: Let's be real, a single misplaced comma, an incorrect reference number, or an inconsistent data point in a regulatory submission can lead to months of delays. Those delays can cost millions in lost revenue or even result in a rejection. With regulators, precision builds credibility. Without it, you're constantly fighting an uphill battle, and your team's work will be scrutinised far more heavily. This isn't just about being tidy; it's about preventing catastrophic errors.

Supporting Traits

• Trait: Resilient
• Desc: You'll face rejection from health authorities and pushback from internal teams who don't 'get' why something needs to change. The ability to absorb that, learn from it, and keep moving forward with a positive attitude is absolutely key here. It's not for the faint-hearted.
• Trait: Diplomatic
• Desc: You'll often be the bearer of bad news—'your project is non-compliant' or 'we can't launch that feature'. You need to deliver these messages in a way that doesn't alienate the very people you need to work with to fix the problem. It's a delicate balance of firmness and understanding.
• Trait: Commercially Astute
• Desc: You need to connect dense, legalistic regulations to real business outcomes: revenue, market share, competitive advantage. It's not enough to just quote the rule; you need to explain its commercial impact and help the business find compliant ways to achieve its goals.
• Trait: Organised & Structured
• Desc: Managing multiple complex international submissions for a product portfolio means juggling a lot of moving parts, deadlines, and documentation. You need a highly organised approach to keep everything on track and ensure nothing falls through the cracks.

Primary Motivators

1. Motivator: Solving Complex Global Puzzles
2. Daily: You get a real buzz from unpicking a brand new, ambiguous international regulation and figuring out the most efficient, compliant pathway for our products. It's like a high-stakes game of chess, but with real-world impact.
3. Motivator: Protecting the Business & Patients
4. Daily: There's a deep satisfaction in knowing your work directly prevents product recalls, avoids massive fines, and ensures our products are safe for use. You're a guardian, really.
5. Motivator: Enabling Market Access & Growth
6. Daily: You love seeing our products successfully launch in new countries. Your efforts directly contribute to the company's growth and reach, which is incredibly rewarding.

Potential Demotivators

Let's be frank, this role isn't for everyone. You'll often feel like you're the 'department of no' because you have to shut down exciting but non-compliant ideas. You'll spend ages translating mind-numbingly dense legal documents into something actionable for engineers who just want to build. You'll also deal with the constant frustration of last-minute requests or finding out that Sales has over-promised a launch date in a country where we haven't even started the regulatory assessment. Sometimes, you'll feel like you're constantly pushing water uphill, especially when regulations change just before launch. If you need immediate, tangible results from every single piece of work, or if you get easily disheartened by bureaucracy and internal friction, you'll probably struggle here.

Common Frustrations

1. Being brought into a product development cycle at the very end, only to discover a fundamental design flaw that violates regulations and forces a costly, last-minute redesign.
2. The constant battle with the commercial team who sell features or promise delivery dates in new countries before you've even started to assess the regulatory pathway.
3. Spending two years developing a product to meet a specific regulation, only for the health authority to publish new 'guidance' three months before launch that changes all the requirements.
4. The internal reputation of being a roadblock or a cost centre, when your actual function is to enable long-term, sustainable market access by preventing catastrophic compliance failures.
5. The thankless task of converting a 300-page, legally dense regulatory document into a 3-page summary of actionable tasks for engineers who just want to know what to build.
6. Submitting a multi-million pound product application and then waiting 6, 12, or even 24 months for a response from a government agency with zero visibility into the process or timeline.

What Role Doesn't Offer

1. A predictable, unchanging work environment – regulations are a moving target.
2. Complete autonomy without needing to influence others – collaboration and persuasion are constant.
3. A role where you're always popular – you'll often have to deliver unwelcome news.
4. A direct path to creating products – your impact is indirect, through ensuring compliance.

ADHD Positives

1. The constant need to switch between different regulations, product lines, and urgent issues can actually be a real strength here, keeping things fresh and engaging.
2. Hyperfocus can be incredibly useful when you need to deep-dive into a complex regulatory document or submission, spotting details others might miss.
3. Your ability to think quickly and adapt to sudden regulatory changes or agency queries can be a huge asset in a fast-moving environment.

ADHD Challenges and Accommodations

1. Managing multiple long-term projects and deadlines can be tough. We can help with structured project management tools (like Jira) and regular, short check-ins to keep things on track.
2. The sheer volume of detailed documentation can be overwhelming. We can explore tools for automated document review and summary generation, and ensure you have support for administrative tasks.
3. Maintaining focus during lengthy, detailed reviews might be challenging. We can build in breaks, vary tasks, and use collaborative review sessions to keep engagement high.

Dyslexia Positives

1. Often, individuals with dyslexia excel at 'big picture' thinking and identifying patterns, which is brilliant for spotting overarching regulatory trends and strategic pathways.
2. Strong verbal communication skills can be a huge advantage when presenting complex regulatory information to non-technical audiences or negotiating with agencies.
3. Your ability to simplify complex concepts and find alternative ways to explain things can be invaluable when translating 'Reg-lish' for other departments.

Dyslexia Challenges and Accommodations

1. Proofreading dense regulatory documents can be particularly challenging. We strongly encourage the use of advanced grammar and spell-checking software, text-to-speech tools, and peer review for critical documents.
2. Organising and structuring large amounts of written information might take more effort. We can provide templates, structured document management systems (like Veeva Vault), and support for outlining complex reports.
3. Reading and interpreting highly technical or legalistic language can be time-consuming. Access to regulatory intelligence platforms with good search and summary functions will be key, along with opportunities for verbal briefings.

Autism Positives

1. Your exceptional attention to detail and ability to spot inconsistencies, especially in highly structured regulatory documents, is a massive advantage.
2. A strong preference for logic, rules, and clear processes aligns perfectly with the compliance nature of this role.
3. Your ability to focus deeply on specific, complex regulatory frameworks can lead to becoming a true subject matter expert, which is highly valued.

Autism Challenges and Accommodations

1. Navigating complex social dynamics and unspoken expectations with diverse internal and external stakeholders can be difficult. We can provide clear communication guidelines, offer coaching on specific stakeholder interactions, and ensure meeting agendas are always explicit.
2. Unexpected changes in regulatory guidance or project priorities can be unsettling. We aim for transparency in communication about changes and provide structured processes for adapting to new information.
3. Sensory sensitivities in an open-plan office might be an issue. We offer noise-cancelling headphones, flexible working arrangements (including remote options), and quiet zones for focused work.

Key Responsibilities

Experience Levels Responsibilities

1. Level: Lead International Regulatory Strategy Director (L4)
2. Responsibilities: Define and refine the regional regulatory strategy for a specific product family or geographical market (e.g., APAC, LATAM). This means figuring out the best way to get our products approved and keeping them compliant in those areas, not just following a pre-set path.
3. Accountable for the successful execution of all regulatory activities within your assigned portfolio. If a submission is late or gets rejected, the buck stops with you. You'll need to figure out what went wrong and fix it.
4. Build and lead a team of Regulatory Affairs Specialists and Senior Specialists. This involves everything from hiring, performance reviews, to daily guidance and making sure they're developing their careers. You're their manager, mentor, and problem-solver.
5. Influence senior stakeholders across Product Development, R&D, and Commercial teams to ensure regulatory requirements are embedded early in the product lifecycle. You'll be the voice of regulatory compliance in those strategic discussions, often pushing back on ideas that look good on paper but are a nightmare for compliance.
6. Architect complex regulatory submissions for novel or high-risk products, ensuring they meet all international agency requirements. This isn't just compiling documents; it's about crafting the narrative and technical arguments that get us approval.
7. Develop and implement proactive horizon scanning processes to identify emerging regulatory changes that could impact our business. You'll need to anticipate problems, not just react to them, and then translate those potential changes into actionable plans for the business.
8. Represent the company in discussions with health authorities and Notified Bodies on significant regulatory matters. This could involve leading pre-submission meetings, responding to complex deficiency letters, or negotiating timelines. You're the face of our regulatory efforts.
9. Supervision: You'll operate with a high degree of autonomy on day-to-day execution and strategic direction within your domain. We'll have monthly strategic alignment meetings with your Senior Manager, but you're expected to drive your own work and your team's output. You're the expert here, so we trust your judgment.
10. Decision: You have full decision-making authority within your assigned product portfolio or region. This includes budget allocation up to £250K for external consultants or tools, hiring and firing decisions for your direct reports, and determining the regulatory pathway for new products. You'll consult with your Senior Manager on significant deviations from global strategy or any budget spend above £250K. Any decisions impacting other departments' P&L or requiring changes to the global QMS will need alignment with relevant department heads.
11. Success: Your success will be measured by your ability to consistently achieve high first-pass approval rates, reduce time-to-market for your portfolio through smart strategy, and develop a high-performing, engaged regulatory team. Ultimately, it's about enabling compliant market access and protecting the business from regulatory risks.

Decision-Making Authority

• Type: Regulatory Pathway Selection for New Product
• Entry: Proposes options, requires full review and approval from Senior Specialist/Manager.
• Mid: Researches and recommends a pathway, requires Manager's approval.
• Senior: Defines and justifies the pathway, consults Director, makes final recommendation to leadership.
• Type: Budget Approval for External Regulatory Consultants
• Entry: Identifies need, provides quotes, requires full approval.
• Mid: Recommends specific consultant, requires Manager's approval.
• Senior: Approves spend up to £10K, recommends higher spend to Director.
• Type: Hiring for Team Members
• Entry: No authority.
• Mid: Participates in interviews, provides feedback.
• Senior: Leads interviews, makes recommendations to Director.
• Type: Response Strategy to Agency Deficiency Letter
• Entry: Drafts initial response based on template, requires full review.
• Mid: Drafts and proposes response, requires Manager's approval.
• Senior: Develops and reviews strategy, consults Director on high-risk responses, approves final submission.

Competency Requirements

Foundation Skills (Transferable)

These are the bedrock skills that let you operate effectively as a leader in a complex regulatory environment. They're not just 'nice-to-haves'; they're essential for getting things done and building a strong team.

• Category: Communication & Influence
• Skills: Negotiation and Persuasion: Getting internal teams and external agencies to see your point of view, even when it's challenging. This means finding common ground and building consensus.
• Executive Presentation: Clearly and concisely explaining complex regulatory strategies and risks to senior leadership, often with significant financial implications.
• Cross-Functional Collaboration: Working seamlessly with R&D, Product, Legal, and Commercial teams to embed regulatory thinking early and avoid last-minute surprises. It's about being a partner, not a police officer.
• Category: Problem-Solving & Decision-Making
• Skills: Strategic Thinking: Looking beyond the immediate problem to anticipate future regulatory challenges and opportunities, then developing long-term plans to address them.
• Risk Assessment & Mitigation: Identifying potential regulatory risks (e.g., new regulations, non-compliance issues), quantifying their impact, and developing robust plans to minimise them.
• Decision-Making Under Ambiguity: Making high-stakes calls when information is incomplete or contradictory, relying on sound judgment and experience.
• Category: Leadership & Development
• Skills: Team Leadership & Management: Guiding, motivating, and developing your direct reports. This includes setting clear objectives, providing constructive feedback, and fostering career growth.
• Mentorship & Coaching: Helping junior members of your team grow their regulatory expertise and navigate complex situations. You're their go-to for advice.
• Change Management: Leading your team and influencing other departments through significant regulatory changes or organisational shifts, ensuring smooth adoption.
• Category: Adaptability & Resilience
• Skills: Navigating Regulatory Complexity: Thriving in an environment where international regulations are constantly evolving and often contradictory, requiring continuous learning and adaptation.
• Dealing with Pressure: Remaining calm and effective when facing tight deadlines, critical agency queries, or internal pushback on regulatory requirements.
• Continuous Learning Mindset: Actively seeking out new information on emerging regulations, industry best practices, and new technologies (like AI) to stay ahead of the curve.

Functional Skills (Role-Specific Technical)

These are the specific methodologies, technical tools, and industry knowledge you'll need to apply day-to-day to lead our international regulatory strategy.

Technical Competencies

• Skill: Regulatory Pathway Assessment (International)
• Desc: You'll be the expert on determining the specific type of submission, timeline, and data required to gain market approval for our products in various target countries (e.g., EU MDR/IVDR, US FDA 510(k)/PMA, Health Canada, TGA, MHRA). This isn't just knowing the pathways; it's about strategically choosing the most efficient one.
• Level: Expert
• Skill: Horizon Scanning & Impact Analysis
• Desc: You'll build and oversee a proactive system for monitoring proposed regulations, lobbying efforts, and competitor submissions globally. Then, you'll quantify their potential operational and financial impact on our business, informing our multi-year product roadmaps and risk strategies.
• Level: Expert
• Skill: Gap Analysis & Remediation Planning
• Desc: You'll lead the structured process of comparing our existing product documentation (DHF, DMR), quality processes (QMS), and testing data against new or updated international regulations. This means identifying shortfalls and creating comprehensive, actionable project plans to close them, often across multiple teams.
• Level: Advanced
• Skill: Regulatory Agency Engagement & Negotiation
• Desc: You'll define and lead our formal and informal communication strategy with key health authorities (e.g., FDA, EMA, Notified Bodies). This includes preparing for scientific advice meetings, responding to complex deficiency letters (RTQs), and managing pre-submission meetings, often negotiating on behalf of the company.
• Level: Expert
• Skill: Change Control Governance (Global)
• Desc: You'll oversee the framework for evaluating any change to a product, process, or supplier—no matter how small—to determine if it requires a notification or a new submission to various international regulatory bodies. This is critical for maintaining compliance post-market.
• Level: Advanced
• Skill: Post-Market Surveillance (PMS) & Vigilance Reporting
• Desc: You'll be responsible for ensuring our systematic process of monitoring a device's real-world performance, collecting user feedback, and fulfilling mandatory incident reporting requirements to regulatory authorities within strict international deadlines. This is about protecting patients and our licence to operate.
• Level: Advanced

Digital Tools

• Tool: ServiceNow GRC / Veeva Vault (QualityDocs/Submissions)
• Level: Advanced
• Usage: Configuring workflows for regulatory submissions, managing user permissions, auditing system data for compliance, and ensuring the platform supports our international regulatory strategy. You'll also train others on its strategic use.
• Tool: Enhesa / RegScan / Thomson Reuters Regulatory Intelligence
• Level: Advanced
• Usage: Building complex queries to track emerging regulations, setting up automated alerts for your portfolio, and synthesising intelligence reports for executive leadership to inform strategic decisions. You're using these to predict the future, not just react to it.
• Tool: Lorenz docuBridge / eCTD Express / Adobe Acrobat Pro (with compliance plugins)
• Level: Expert
• Usage: Overseeing the entire submission publishing lifecycle, troubleshooting complex validation errors, and ensuring compliance with various agency e-submission gateways globally. You'll define the standards for your team's publishing activities.
• Tool: MS Teams (with SharePoint integration) / Jira / Confluence
• Level: Advanced
• Usage: Designing Jira workflows for complex international regulatory projects, building comprehensive Confluence knowledge bases for your team, and architecting SharePoint site structures to ensure a single source of truth for all regulatory activities across your portfolio.
• Tool: Power BI / Tableau Server
• Level: Advanced
• Usage: Building and maintaining sophisticated dashboards that track submission status, agency response times, and key departmental performance indicators (KPIs) for your portfolio. You'll use these to present clear, data-driven insights to senior leadership.

Industry Knowledge

• Area: Global Regulatory Landscape
• Desc: Deep understanding of the regulatory frameworks in key markets such as the EU (MDR/IVDR), US (FDA), UK (MHRA), Canada (Health Canada), Australia (TGA), and major APAC/LATAM regions. This includes knowing the nuances and differences between them.
• Area: Product Lifecycle Management (Regulatory Perspective)
• Desc: Understanding how regulatory requirements impact every stage of a product's life, from R&D and design control through manufacturing, post-market surveillance, and eventual decommissioning.
• Area: Quality Management Systems (QMS)
• Desc: Thorough knowledge of ISO 13485 and 21 CFR Part 820, and how they integrate with regulatory submissions and ongoing compliance. You'll need to ensure our QMS supports our international regulatory strategy.
• Area: Clinical Data & Evidence Requirements
• Desc: Understanding the types of clinical data and evidence required for various international regulatory submissions, and how to interpret clinical study reports from a regulatory perspective.

Regulatory Compliance Regulations

• Reg: EU Medical Device Regulation (MDR 2017/745) & IVDR (2017/746)
• Usage: You'll be leading the strategy for CE marking, technical documentation, clinical evaluation, and post-market surveillance for all products entering or remaining in the EU market. This includes managing interactions with Notified Bodies and navigating ongoing guidance changes.
• Reg: US FDA (21 CFR Parts 800-1299, 510(k), PMA)
• Usage: You'll be defining and overseeing the strategy for US market access, including pre-market submissions (510(k), PMA), pre-submission meetings, Q-submissions, and ensuring compliance with post-market requirements. You'll also manage responses to FDA observations (e.g., 483s).
• Reg: UK MHRA Regulations (Post-Brexit)
• Usage: You'll be responsible for understanding and implementing the specific requirements for placing products on the Great Britain market, including UKCA marking, and managing any divergence from EU regulations. This is a constantly evolving area, so staying on top of it is key.
• Reg: Health Canada Medical Device Regulations
• Usage: You'll lead the strategy for obtaining Medical Device Licences (MDLs) in Canada, ensuring compliance with their specific classification rules, quality management system requirements, and post-market vigilance reporting.
• Reg: APAC & LATAM Regional Regulations (e.g., TGA, MHLW, ANVISA)
• Usage: You'll oversee the regulatory strategies for key markets in Asia-Pacific and Latin America, adapting global strategies to local requirements and managing local regulatory partners where necessary. This often involves navigating complex local nuances.

Essential Prerequisites

• Demonstrable experience (8+ years) in a dedicated regulatory affairs role within the medical device, pharmaceutical, or IVD industry, with a significant focus on international markets.
• Proven track record of successfully leading complex regulatory submissions (e.g., novel devices, new market entries) from start to finish, achieving market approvals.
• Experience managing or formally mentoring junior regulatory professionals, including providing guidance on complex issues and supporting their development.
• A deep, practical understanding of at least two major international regulatory frameworks (e.g., EU MDR and US FDA) and how to apply them strategically.
• Experience in engaging directly with health authorities or Notified Bodies, including leading meetings and negotiating outcomes.
• A solid grasp of Quality Management Systems (e.g., ISO 13485) and their interplay with regulatory compliance.

Career Pathway Context

When you join us, we'll expect you to hit the ground running with a strong foundation in international regulatory affairs. This isn't a role where you'll be learning the basics of submissions or regulatory frameworks. Instead, we're looking for someone who can immediately step in, take ownership of a product portfolio or region, and start shaping our strategy. If you've been a Senior Specialist who's led projects end-to-end and started to mentor others, you're probably in a good spot.

Qualifications & Credentials

Emerging Foundation Skills

• Skill: AI-Driven Regulatory Intelligence & Prediction
• Why: Honestly, the volume of regulatory changes globally is just too much for humans to track effectively. AI tools are getting incredibly good at scanning, summarising, and even predicting regulatory shifts. Those who can use these tools effectively will have a massive strategic advantage, spotting opportunities and risks long before competitors.
• Concepts: [{'concept_name': 'Natural Language Processing (NLP) for regulatory text analysis', 'description': "Understanding how AI can 'read' and interpret legalistic regulatory documents to extract key requirements and changes."}, {'concept_name': 'Predictive Analytics for regulatory trends', 'description': 'Using historical data and current events to forecast future regulatory directions and potential agency focus areas.'}, {'concept_name': 'Prompt Engineering for regulatory queries', 'description': 'Crafting effective prompts for LLMs to generate accurate summaries, identify gaps, or draft responses to agency questions.'}, {'concept_name': 'Ethical AI use in compliance', 'description': 'Understanding the limitations, biases, and legal implications of using AI for regulatory tasks, especially around data privacy and accuracy.'}]
• Prepare: This month: Start experimenting with public LLMs (ChatGPT, Claude) to summarise complex regulatory articles or draft initial policy statements. See what works and what doesn't.
• Next quarter: Explore how our existing regulatory intelligence platforms (e.g., Enhesa) are integrating AI features. Push for access to these new capabilities.
• Month 3-6: Take an online course on prompt engineering or AI fundamentals. You don't need to be a data scientist, but understanding the basics will be crucial.
• Month 6-12: Lead a pilot project within your team to use AI for a specific regulatory task, like drafting initial responses to routine agency queries, and measure the time savings and accuracy.
• QuickWin: Today, use an LLM to help you draft an internal email explaining a complex regulation in simpler terms. It's a low-risk way to start seeing the benefit.
• Skill: Digital Health & Software as a Medical Device (SaMD) Regulation
• Why: The healthcare landscape is rapidly digitising, and software is increasingly becoming a medical device in its own right. Traditional regulatory frameworks often struggle with the pace and nature of software development. As we move more into digital solutions, understanding these specific regulations will be paramount for market access.
• Concepts: [{'concept_name': 'IEC 62304 (Software Life Cycle Processes)', 'description': 'Understanding the international standard for medical device software life cycle processes and its regulatory implications.'}, {'concept_name': 'FDA Guidance on SaMD and Digital Health', 'description': 'Deep dive into the specific guidance documents from the FDA regarding software as a medical device, including pre-cert programs.'}, {'concept_name': 'EU MDR Annex I General Safety and Performance Requirements (GSPR) for software', 'description': 'Understanding how the MDR applies to software, including cybersecurity and data protection aspects.'}, {'concept_name': 'Cybersecurity in Medical Devices', 'description': 'The critical regulatory requirements and best practices for ensuring the cybersecurity of connected medical devices and SaMD.'}]
• Prepare: This month: Identify any existing or planned digital health products in our pipeline. Start reading the relevant FDA and EU guidance documents.
• Next quarter: Attend a webinar or industry event focused specifically on SaMD or digital health regulation. Network with peers in this space.
• Month 3-6: Work with our R&D software teams to understand their development processes and identify potential regulatory gaps for SaMD.
• Month 6-12: Lead the development of an internal policy or guidance document for our company's approach to SaMD regulation, ensuring it's integrated into our QMS.
• QuickWin: Review the cybersecurity section of our latest medical device submission. Are we meeting current best practices? What's missing for SaMD?

Advancing Technical Skills

• Skill: Advanced GRC/QMS Platform Optimisation
• Why: Our GRC and QMS platforms (like Veeva Vault or ServiceNow) are becoming central to all compliance activities. As a Director, you'll need to move beyond just using them to actively optimising and integrating them. This means ensuring they truly support our global regulatory strategy, not just act as a document repository.
• Concepts: [{'concept_name': 'Workflow Automation & Orchestration', 'description': 'Designing and implementing complex automated workflows within the GRC/QMS to streamline regulatory processes (e.g., change control, CAPA management, submission tracking).'}, {'concept_name': 'API Integration with Enterprise Systems', 'description': 'Understanding how to connect our GRC/QMS with other critical systems (like ERP, CRM) to ensure data consistency and reduce manual data entry across the organisation.'}, {'concept_name': 'Advanced Reporting & Analytics', 'description': 'Building custom reports and dashboards within the platform to provide real-time insights into regulatory performance, compliance status, and risk exposure.'}, {'concept_name': 'User Experience (UX) Design for Compliance', 'description': 'Ensuring the platform is intuitive and easy for all users, driving adoption and reducing errors, which ultimately improves compliance.'}]
• Prepare: This month: Deep-dive into the advanced features and configuration options of our current GRC/QMS platform. Talk to the system administrators.
• Next quarter: Identify one manual, repetitive process in your team's workflow that could be automated within the GRC/QMS. Design a solution.
• Month 3-6: Participate in vendor webinars or user groups for our GRC/QMS platform to learn about upcoming features and best practices for optimisation.
• Month 6-12: Lead a project to implement a significant improvement or integration within the GRC/QMS that directly supports a key regulatory objective for your portfolio.
• QuickWin: Identify a common data entry error in our QMS. Can you propose a simple validation rule or workflow change to prevent it?

Education Requirements

• Level: Minimum
• Req: A Bachelor's degree in a scientific discipline (e.g., life sciences, biomedical engineering, chemistry), law, or a related field.
• Alts: We're open to candidates with equivalent practical experience (typically 12+ years in regulatory affairs) if you can demonstrate the depth of knowledge and strategic thinking that a degree would provide. Show us what you've done, not just where you studied.
• Level: Preferred
• Req: A Master's degree (MSc, MBA, LLM) in Regulatory Affairs, Science, or Business.
• Alts: Not strictly necessary, but it definitely shows a commitment to the field and can provide a broader strategic perspective. If you don't have one, make sure your experience speaks for itself.

Experience Requirements

You'll need at least 8-12 years of progressive experience in regulatory affairs, specifically within the medical device, pharmaceutical, or IVD industries. A significant portion of this experience (at least 5 years) must be focused on international markets and complex submissions. We're looking for someone who has led major regulatory projects, managed a portfolio of products, and ideally, has some experience directly managing or heavily mentoring a team of regulatory professionals. This isn't your first rodeo; you've seen a few regulatory cycles and know how to navigate them.

Preferred Certifications

• Cert: Regulatory Affairs Certification (RAC)
• Prod: RAPS (Regulatory Affairs Professionals Society)
• Usage: This is widely recognised in the industry and demonstrates a solid understanding of global regulatory requirements and practices. It tells us you're serious about your craft.
• Cert: Certified Quality Auditor (CQA) or similar
• Prod: ASQ (American Society for Quality) or equivalent
• Usage: Understanding quality system auditing is incredibly helpful for a regulatory role, especially when conducting gap analyses or preparing for health authority inspections. It shows you know what auditors are looking for.
• Cert: Project Management Professional (PMP)
• Prod: PMI (Project Management Institute)
• Usage: Leading complex international regulatory projects requires strong project management skills. This certification shows you've got the structured approach needed to keep things on track, especially when juggling multiple submissions and teams.

Recommended Activities

• Regularly attend industry conferences (e.g., RAPS Regulatory Convergence, MedTech Forum) to stay updated on emerging trends and network with peers.
• Participate in relevant industry association working groups or committees to influence regulatory policy and best practices.
• Engage in continuous learning through online courses, webinars, and publications focused on new regulations (e.g., digital health, AI in medical devices) and market-specific requirements.
• Seek out mentorship opportunities, either formally or informally, from senior leaders within the regulatory field.

Career Progression Pathways

Entry Paths to This Role

• Path: Senior Regulatory Affairs Specialist (L3) to Director
• Time: 3-5 years as a Senior Specialist
• Path: Regulatory Affairs Manager (from a smaller company) to Director
• Time: 2-4 years as a Manager in a smaller, less complex organisation
• Path: Regulatory Consultant to Director
• Time: 5-8 years in a senior consulting role, focusing on international regulatory strategy

Career Progression From This Role

• Pathway: Senior Manager, International Regulatory Strategy (L5)
• Time: 3-5 years in this Director role

Long Term Vision Potential Roles

• Title: VP, International Regulatory Affairs
• Time: 5-8 years from this Director role
• Title: Chief Compliance & Regulatory Officer (CCRO)
• Time: 8-12+ years from this Director role
• Title: Head of Global Market Access & Regulatory Policy
• Time: 6-10 years from this Director role

How Zavmo Delivers This Role's Development

DISCOVER Phase: Skills Gap Analysis

Zavmo maps your current competencies against all requirements in this job description through conversational assessment. We evaluate your foundation skills (communication, strategic thinking), functional skills (CRM expertise, negotiation), and readiness for career progression.

Output: Personalised skills gap heat map showing strengths and priorities, estimated time to competency, neurodiversity accommodations.

DISCUSS Phase: Personalised Learning Pathway

Based on your DISCOVER results, Zavmo creates a personalised learning plan prioritised by impact: foundation skills first, then functional skills. We adapt to your learning style, pace, and neurodiversity needs (ADHD, dyslexia, autism).

Output: Week-by-week schedule, each module linked to specific job responsibilities, checkpoints and milestones.

DELIVER Phase: Conversational Learning

Learn through conversation, not boring modules. Zavmo uses 10 conversation types (Socratic dialogue, role-play, coaching, case studies) to build competence. Practice difficult QBR presentations, negotiate tough renewals, and handle churn conversations in a safe AI environment before facing real clients.

Example: "For 'Stakeholder Mapping', Zavmo will guide you through analysing a complex enterprise account, identifying key decision-makers, and building an engagement strategy."

DEMONSTRATE Phase: Competency Assessment

Zavmo automatically builds your evidence portfolio as you learn. Every conversation, practice scenario, and application example is captured and mapped to NOS performance criteria. When ready, your portfolio supports OFQUAL qualification claims and demonstrates competence to employers.

Output: Competency matrix, evidence portfolio (downloadable), qualification readiness, career progression score.